Class II · Moderate risk
fentaNYL Citrate
Labeling: Not Elsewhere Classified: Complaint received on 08/31/2026 regarding the discrepancy of the IV bag expiry (07/31/2026 and 11/30/2026) and the product expiry (12/09/2026).
FDA Drug Recalls
40 recalls · Class II, newest first
Class II · Moderate risk
Dextroamphetamine Saccharate
Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.
Class II · Moderate risk
Perampanel CIII Tablets
Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.
Class II · Moderate risk
Aripiprazole Tablets USP
Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg.
Class II · Moderate risk
Xyvona (levorphanol tartrate tablets)
Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona
Class II · Moderate risk
Xyvona (levorphanol tartrate tablets)
Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona
Class II · Moderate risk
Gas-X
Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.
Class II · Moderate risk
Atomoxetine Capsules HCL
Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.
Class II · Moderate risk
Albuterol Sulfate Inhalation Solution
Labelling: Illegible label
Class II · Moderate risk
methylprednisolone tablets
Labeling: Not Elsewhere Classified. Incorrect orientation of the blister foil applied to the blister cavities, which results in incorrect dosing information when following the directions on the foil.
Class II · Moderate risk
Levothyroxine Sodium Tablets
Product Mix-Up: A single bottle of this lot was reported by a pharmacy to contain 88 mcg tablets instead of 150 mcg tablets.
Class II · Moderate risk
Acetaminophen 500mg Caffeine 65mg caplets
Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingredients Acetaminophen 500mg and Caffeine 65mg. The inner pouch correctly states the ingredients are Aspirin (NSAID)*500mg and Caffeine 32.5mg.
Class II · Moderate risk
Haloperidol Lactate Injection
Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.
Class II · Moderate risk
Carbidopa
Product mix up: complaint received that sealed medication bottle contained Carbidopa, Levodopa, and Entacapone film-coated tablets (37.5 mg/150 mg/200 mg) instead of labelled lower strength Carbidopa, Levodopa, and Entacapone film-coated tablets (25 mg/100 mg/200 mg).
Class II · Moderate risk
Zicam" Medicated Fruit Drops Elderberry Flavor
Labeling: Label Mix-up: The product in the bottle contains elderberry and the label failed to indicate the inclusion of elderberry as an ingredient.
Class II · Moderate risk
Sting Relief Swabs
Product Mix-up
Class II · Moderate risk
Enoxaparin Sodium Injection
Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL
Class II · Moderate risk
Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg
Product Mix Up: This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20mg/12.5 mg had a foreign tablet identified as atazanavir and ritonavir tablet 300mg/100mg.
Class II · Moderate risk
Dexonto 0.4%
Labeling: Incorrect or Missing Lot and/or Expiration date: Individual vials of Dexonto 0.4%, are labeled correctly with the BUD of 12/25/2024, however, the outer box on some of the Dexonto 0.4% are labeled incorrectly with a BUD of 12/25/2025.
Class II · Moderate risk
[CORRECT FRONT PANEL] Hydrogen Peroxide Topical Solution
Labeling; Label Mixup; some bottles have an incorrect back label indicating 91% Isopropyl Alcohol
Class II · Moderate risk
Regadenoson Injection
Labeling: Missing Label
Class II · Moderate risk
Sunitinib Malate Capsules
Labeling: Label Mix-Up
Class II · Moderate risk
Sunitinib Malate Capsules
Labeling: Label Mix-Up
Class II · Moderate risk
Norepinephrine Bitartrate in 5% Dextrose Injection
Incorrect product concentration on the overwrap label: The overwrap label incorrectly identified the product strength as 4 mg / 250 mL; however, the primary bag label correctly identified the product strength as 8 mg / 250 mL.
Class II · Moderate risk
Hydrogen Peroxide Oral Rinse
CGMP Deviations: products may not conform to the labeled specifications.